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<\/p>\nWashington, DC…Following a thorough safety review, including two meetings of the CDC\u2019s Advisory Committee on Immunization Practices, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention have determined that the recommended pause regarding the use of the Janssen (Johnson & Johnson) COVID-19 Vaccine in the U.S. should be lifted and use of the vaccine should resume.<\/p>\n
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The pause was recommended after reports of six cases of a rare and severe type of blood clot in individuals following administration of the Janssen COVID-19 Vaccine. During the pause, medical and scientific teams at the FDA and CDC examined available data to assess the risk of thrombosis involving the cerebral venous sinuses, or CVST (large blood vessels in the brain), and other sites in the body (including but not limited to the large blood vessels of the abdomen and the veins of the legs) along with thrombocytopenia, or low blood platelet counts. The teams at FDA and CDC also conducted extensive outreach to providers and clinicians to ensure they were made aware of the potential for these adverse events and could properly manage and recognize these events due to the unique treatment required for these blood clots and low platelets, also known as thrombosis-thrombocytopenia syndrome (TTS).<\/p>\n
The two agencies have determined the following:<\/p>\n
CDC\u2019s independent Advisory Committee on Immunization Practices\u00a0met today to discuss<\/a>\u00a0the latest data on TTS, hearing from the vaccine manufacturer Janssen and the COVID-19 Vaccine Safety Technical (VaST) Subgroup, as well as a risk benefit analysis. ACIP is committed to be vigilant and responsive to additional information that could impact the risk benefit analysis of any of these vaccines. Vaccine safety monitoring will continue and any new information about TTS will be brought to ACIP as needed.<\/p>\n \u201cSafety is our top priority. This pause was an example of our extensive safety monitoring working as they were designed to work\u2014identifying even these small number of cases. We\u2019ve lifted the pause based on the FDA and CDC\u2019s review of all available data and in consultation with medical experts and based on recommendations from the CDC\u2019s Advisory Committee on Immunization Practices. We have concluded that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older. We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality. We recommend people with questions about which vaccine is right for them have those discussions with their health care provider,\u201d said Janet Woodcock, M.D., Acting FDA Commissioner.<\/p>\n \u201cAbove all else, health and safety are at the forefront of our decisions,\u201d said CDC Director Dr. Rochelle P. Walensky. \u201cOur vaccine safety systems are working. We identified exceptionally rare events \u2013 out of millions of doses of the Janssen COVID-19 administered \u2013 and we paused to examine them more carefully. As we always do, we will continue to watch all signals closely as more Americans are vaccinated. I continue to be encouraged by the growing body of real-world evidence that the authorized COVID-19 vaccines are safe and effective, and they protect people from disease, hospitalization, and death. I urge anyone with questions about the COVID-19 vaccines to speak with their healthcare provider or local public health department.\u201d<\/p>\n Assessment of Available Data<\/strong><\/p>\n Medical and scientific teams at the FDA and CDC reviewed several sources of information and data related to the Janssen COVID-19 Vaccine to reach today\u2019s decision.<\/p>\n Specifically, the agencies assessed reports submitted to the\u00a0Vaccine Adverse Event Reporting System (VAERS),external icon<\/span><\/a>\u00a0reviewed the medical literature and considered the information from global regulatory partners about thrombosis with thrombocytopenia that have been reported following use of a similar, yet not identical, COVID-19 vaccine using a virus from the adenovirus family that has been modified to contain the gene for making a protein from SARS-CoV-2.<\/p>\n Update on Adverse Events<\/strong><\/p>\n On April 13, the FDA and CDC\u00a0announcedexternal icon<\/span><\/a>\u00a0that, out of more than 6.8 million doses administered, six reports of a rare and severe type of blood clot combined with low blood platelet levels occurring in people after receiving the Janssen COVID-19 Vaccine had been reported to VAERS. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia).<\/p>\n Today, the agencies can confirm that a total of 15 cases of TTS have been reported to VAERS, including the original six reported cases. All of these cases occurred in women between the ages of 18 and 59, with a median age of 37 years. Reports indicated symptom onset between 6 and 15 days after vaccination.<\/p>\n Monitoring for Safety Will Continue<\/strong><\/p>\n The surveillance systems that are in place to monitor the safety of COVID-19 vaccines authorized for emergency use are working, as demonstrated by both agencies\u2019 quick work to identify and investigate these rare, but serious adverse events. The FDA and CDC will continue with these efforts to closely monitor the safety of these vaccines.<\/p>\n Reports of adverse events following vaccination can be made to the\u00a0Vaccine Adverse Event Reporting Systemexternal icon<\/span><\/a>.<\/p>\n Additional Resources:<\/strong><\/p>\n\n
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